BR112015013198B1 - MULTILAYER FILM AND THERMOFORMED BLISTER PACKAGE OBTAINED FROM THIS FILM - Google Patents

Abstract

multilayer film the present application describes a multilayer film that has low permeability to water vapor. the multilayer film of the present application is readily thermoformed and is therefore suitable for blister-type packaging blades, as well as for food packaging, drug barriers and device packaging, and other general purposes where the low vapor permeability of water is desired.

Description

FIELD OF THE TECHNIQUE OF THE INVENTION

[0001] The present application describes a multilayer film that has low permeability to water vapor. The multilayer film of the present application is readily thermoformed and is therefore suitable for blister-type packaging blades, as well as for food packaging, drug barriers and device packaging, and other general purposes where the low vapor permeability of water is desired.

BACKGROUND OF THE INVENTION

[0002] A packaging for pharmaceuticals and other medical accessories typically employs multilayer films to provide adequate barriers to moisture and dust to maintain the integrity of the items contained in the packaging. Conventional films used in these applications contain one or more polymers that are formed from halogenated molecules, such as polyvinyl chloride (PVC), polyvinylidene chloride (PVdC) or fluorinated chlorinated resins, such as poly-chloro-tri-fluoro-fluorine ethylene (PCTFE). Although the films that incorporate these resins provide effective barriers, the manufacture and disposal of these films can result in unwanted effects and sometimes dangerous by-products. For example, dioxin can be formed from the production and disposal of PVC, and PVdC can cause excessive corrosion of packaging equipment and machinery.

[0003] The production of multilayer films and the use of such films in a variety of packaging applications are well known. Multilayer films can be produced in a variety of ways and often include the extrusion or coextrusion steps, followed by adhesive or thermal lamination, extrusion lamination and / or extrusion coating. However, some films can only be produced by coextrusion.

[0004] Coextrusion of multilayer films is well known in the art and includes films blown by coextrusion and fused films, as described, for example, in Patent Nos. U.S. 3,479,425, U.S. 3,797,987, U.S. 3,959,431 and U.S. 4,406,547. Multilayer films can be produced by coextruding two or more melt streams through a matrix, to produce a layered structure when allowed to cool. Coextruded films can be further laminated to other layers of film or can be coated with additional polymers to incorporate more layers into a final film product. Since not all polymers readily adhere to one another, some films may also incorporate layers that contain adhesive or bonding which facilitate the adhesion of two or more layers to a film. These bonding layers can be coextruded with the other polymeric layers or can be introduced during a lamination process.

[0005] Packaging for pharmaceuticals or other moisture-sensitive materials requires not only low moisture permeability, but also other properties, such as chemical inertness, clarity, stiffness or uniform thickness. The properties of the finished film, such as the total thickness, can be controlled by the relative speed and output of the individual extruders that distribute the melt streams to the matrix. In addition, the melting temperatures and polymer viscosity of the individual polymers can affect the thickness and adhesion of the layers to each other after extrusion. However, many of the desired finished film properties are unique to each layer within the multilayer film and can therefore make coextrusion of certain films very challenging.

[0006] Multilayer films can be formed on the packaging by submitting them to a thermoforming process. Plastic thermoforming processes are well known in the art and are described, for example, in U.S. Patent Nos. 4,421,721, U.S. 4,994,229, U.S. 5,106,567 and U.S. 6,086,600. Generally, thermoforming is a process for forming a plastic packaging or container structure by heating a sheet of plastic film to a desired forming temperature and shaping the film by subjecting it to vacuum or pressure shaping in a mold.

[0007] Thermoformed blister packaging is often used for commercial packaging of food products, personal care products and products for human health, such as pharmaceuticals and medical devices or other accessories. The use of this type of packaging has expanded, mainly due to the ability to incorporate the appropriate moisture, dust, UV and / or gas barriers into the packaging, when such properties are desired to keep the product contained in the packaging. For example, the pharmaceutical blister pack is effective for maintaining the integrity of the medicine tablet. However, the common packaging currently contains typically the unwanted halogenated polymers described above.

[0008] So, there is still a need for packaging multilayer and thermoformed films, especially for pharmaceutical products, which is free of halogenated polymers, is chemically inert and non-corrosive, and is aesthetically pleasing enough to present the products contained therein. , is durable enough to protect the contents of the package, and has the capacity to be produced on existing equipment in pharmaceutical finishing / filling plants.

SUMMARY OF THE INVENTION

[0009] The present application describes a multilayer film, with desired water vapor barrier properties, which is substantially free of halogenated polymers.

[0010] In a first aspect, the present application describes a multilayer film comprising a first layer, a second layer and a third layer, wherein the first and third layers comprise a substantial and chemically inert halogen-free polymer, and the The second layer comprises high density polyethylene (HDPE), a nucleating agent, and a hydrocarbon resin, and where the second layer is between the first and the third layers, and where a bonding layer is between the first and the second second layers and between the second and third layers.

[0011] In a second aspect, the present application describes a thermoformed blister package, formed from a multilayer film comprising a first layer, a second layer and a third layer, the first and third layers comprising a substantial and chemically inert halogen-free polymer, and the second layer comprises HDPE, a nucleating agent, and a hydrocarbon resin, and where the second layer is between the first and the third layers, and where a bonding layer is between the first and second layers and between the second and third layers.

[0012] And a third aspect, the present application describes a coextrusion process in mold which comprises forming a first layer comprising a substantial and chemically inert halogen-free layer; forming a second layer comprising HDPE, a nucleating agent and a hydrocarbon resin; forming a third layer comprising a substantial and chemically inert halogen-free layer; forming a bonding layer between the first and second layers and between the second and third layers, wherein the bonding layers comprise a bonding resin, HDPE, and a nucleating agent; coextruding the first, second, third and connecting layers in an extrudate; and cooling the extrudate in a cooling cylinder to form a five-layer multilayer film.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 is a schematic representation of a cross-sectional view of an embodiment of the multilayer film of the present application.

[0014] Figure 2 is a perspective view of a blister-type package, according to an embodiment of the present application.

[0015] Figure 3 is a bottom plan view of a blister-type package, according to another embodiment of the present application.

[0016] Figure 4 is a side plan view of a blister pack, according to an additional embodiment of the present application.

[0017] Figure 5 is a graphical representation of a modality of an effective rheology profile of a substantial and chemically inert halogen-free polymer.

[0018] Figure 6 is a graphical representation of another modality of an effective rheology profile of a substantial and chemically inert halogen-free polymer.

DETAILED DESCRIPTION OF THE INVENTION

[0019] The present application describes a multilayer film substantially free of halogenated polymers, which has desirable and useful moisture barrier properties for preparing thermoformed blister packs.

[0020] As used herein, the term "polymer" refers to a macromolecule composed of structural repeating units and includes homopolymers, copolymers and heteropolymers. Then, as used herein, polymeric materials can comprise polymers, copolymers or mixtures thereof.

[0021] As used herein, the term "halogenated polymers" refers to polymers that contain one or more halogen atoms in the polymer's main repeating chain. Examples of such polymers include PVC, PVdC and PCTFE.

[0022] As used herein, the term "multilayer" means a plurality of layers in a single film, generally in the form of a blade or web, which can be produced from polymeric or non-polymeric materials bonded by conventional means known in the art , for example, lamination, coextrusion and the like.

[0023] As used in this document, the term "coextrusion" means the process of extruding two or more polymer materials, through a single matrix with two or more orifices arranged, so that the extrudates are immersed and melted together in a laminated structure, before cooling or tempering. Coextrusion methods are known to those skilled in the art and include, but are not limited to, blow coextrusion and mold coextrusion. The flat die or slit die casting fusion process includes extruding the polymer streams through a slit or flat die in a cooled cylinder and subsequently wrapping the film in a core to form a film cylinder for further processing. In one embodiment, the multilayer film of the present application is prepared by a coextrusion process in a flat die mold.

[0024] As used in this document, the term "blown film" means a film produced by the blown coextrusion process. In the blowing coextrusion process, the streams of fused plastic polymers are forced through an annular matrix that has a central mandrel to form a tubular extrudate. The tubular extrudate can be expanded to a desired wall thickness by a volume of fluid, air or other gas, which enters the hollow part of the extrudate, through the mandrel, and then quickly cooled or tempered by any one of several methods known to those skilled in the art.

[0025] As used in this document, the term "layer" refers to a distinct component of a film or film that is coextensive with the film or film and that has a substantially uniform composition. So, in a monolayer film, the terms "film," "blade" and "layer" are synonymous.

[0026] As used in this document, the term "barrier" refers to a material that controls the permeability of one or more elements that include, moisture, chemicals, heat, odor and oxygen or other gases. Since the same applies to multilayer films, the barrier can be provided by a single layer or multiple layers that act together or individually. For example, a moisture barrier refers to a material that limits the permeability of water vapor through the material. In one embodiment, the multilayer film of the present application comprises a moisture barrier.

[0027] As used herein, the term "bonding layer" or "bonding material" refers to a polymeric material that has the primary function of adhering one layer of film to another. The bonding layer can comprise polymers or polymer blends, with or without modification, which provide superior adhesion of the layers adjacent to each other, as compared to the adhesion of the adjacent layers, without the presence of the bonding layer. The reference to "a bonding layer" or "bonding material" includes a single bonding resin or a mixture of two or more resins. In one embodiment, the bonding layers comprise bonding resin from about 70% to about 95% by weight of the layer.

[0028] As used herein, the term "high density polyethylene" or "HDPE" refers to ethylene homopolymers that have densities from about 0.960 g / cm3 to about 0.970 g / cm3, as well as ethylene copolymers and an alpha-olefin (such as 1-butene or 1-hexene) which have densities from about 0.940 g / cm3 to about 0.958 g / cm3. HDPE is inclusive of polymers produced with Ziegler or Phillips-type catalysts and polymers produced with single-site metallocene catalysts. HDPE also refers to high molecular weight polyethylenes. In contrast to HDPE, in which polymers that contain some branched "high molecular weight ultrapoliethylenes" are primarily unbranched and are of a molecular weight that is significantly higher than that of an HDPE. In a multi-layer film embodiment of the present application, the bonding layer comprises from about 5% to about 25% HDPE by weight of the layer. In another embodiment, the bonding layer comprises from about 18% to about 22% HDPE by weight of the layer. In another embodiment, the second layer comprises from about 60% to about 95% HDPE by weight of the layer.

[0029] As used herein, the term "low density polyethylene" or "LDPE" refers to a branched homopolymer that has a density of about 0.915 g / cm3 to about 0.930 g / cm3, as well as copolymers that contain polar groups that result from copolymerization, such as with vinyl acetate or ethyl acrylate. LDPE typically contains a primary backbone with branching alkyl substituents of two to eight carbon atoms in length.

[0030] As used herein, the term "nucleating agent" means a composition that provides an active surface for polymer absorption and elevates polymer crystallinity as a result. Such nucleating agents typically provide better control over crystallization rates. Examples of nucleating agents include minerals, such as chalk, talc, clay, kaolin, silicates and the like and organic agents, such as salts of carboxylic, aromatic or aliphatic acids, aromatic salts, metal salts of aromatic phosphorus compounds, quinaridones, and aromatic starches. In addition, examples include zinc gicerolate, calcium gicerolate, calcium hexahydrophthalate, zinc hexahydrophthalate, salts and the like, and mixtures thereof. In one embodiment, the nucleating agent comprises calcium hexahydrophthalate. In one embodiment, the nucleating agent is present in the binding layer from about 0.2% to about 3.5% by weight of the layer. In another embodiment, the nucleating agent is present in the second layer from about 0.01% to about 3.0% by weight of the layer.

[0031] As used herein, the term "hydrocarbon resin" refers to a product produced by polymerization from coal tar, petroleum and turpentine raw materials, as defined by Standard ISO 472, "Plastics - Vocabulary ", incorporated by reference in this document as it teaches about hydrocarbon resins. The reference to "a hydrocarbon resin" includes pure resins of a single class or a mixture of two or more classes. In one embodiment, the hydrocarbon resin is present in the second layer from about 3% to about 16% by weight of the layer. In another embodiment, the hydrocarbon resin is present in the second layer from about 5% to about 10% by weight of the layer.

[0032] As used herein, the term "halogen-free polymer" refers to polymers that are halogen-free in the polymer backbones. Such polymers can contain residual halogens from one or more halogen-containing catalysts used in the production of the polymers.

[0033] As used herein, the term "substantial and chemically inert polymer" refers to polymers that are generally not reactive with other elements and do not contain components, such as styrene, which can stick from the polymeric film layer. Examples of substantially and chemically inert polymers include aromatic polyesters, such as polyethylene terephthalate (PETG), polyethylene that includes HDPE and LDPE, polypropylene, polyethylene naphthalate (PEN), polybutylene terephthalate (PBT), polylactic acid (PLA) and cyclic olefin copolymers (COC).

[0034] As used herein, the term "aromatic polyesters" means the polyester that can be considered the polymeric product obtained by polycondensing a diol and a dicarboxylic acid, at least part of the diol and / or the dicarboxylic acid it contains an aromatic ring. Examples of aromatic polyesters include polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), crystalline polyethylene terephthalate (CPET), glycol modified polyethylene terephthalate (PETG) and polybutylene terephthalate (PBT). In one embodiment, the aromatic polyester of the multilayer film of the present application is PETG.

[0035] As used herein, the term "palindromic film" refers to a multilayer film that is substantially symmetrical. Examples of palindromic films have structures, such as A / B / C / B / A, A / B / B / A, or A / B / A. Palindromic films can be produced by coextrusion, lamination or any other methods known in the art. One method for preparing palindromic films is a blow-coextrusion process, in which the multilayer film is blown and coextruded into a tube, flattened on itself, and then thermally laminated to create a single core layer, from of the two identical internal “layers” of the flattened tube. Another method for preparing palindromic films is a coextrusion process in a mold in which the resins are extruded through a slit or flat die in a cold cylinder and progressively cooled. In an embodiment of the multilayer film of the present application, the multilayer film is a palindromic film. In an additional embodiment, the multilayer film is a five-layer palindromic film, formed in a coextrusion process in a mold.

[0036] As used in this document, the term "thermoformed" means a film or sheet that is formed in a desired shape by applying a differential pressure between the film and a mold, by applying heat or a combination thereof. Many thermoforming methods are known in the art.

[0037] As used in this document, the term "mil" or "mils" means one thousandth of an inch, and is used to describe the thickness of a layer, blade or film. In an embodiment of the multilayer film of the present application, the thickness of the multilayer film is from about 0.127 mm (5 mils) to about 0.635 mm (25 mils). In an additional embodiment, the thickness of the multilayer film is about 0.254 mm (10 mils) to about 0.533 mm (21 mils). In yet another embodiment, the multilayer film thickness is about 0.254 mm (10 mils), about 0.305 mm (12 mils), about 0.381 mm (15 mils), about 0.457 mm (18 mils) or about 0.533 mm (21 mils).

[0038] The multilayer film of the present application can be produced with layers of various weights and thicknesses to produce a final film product that is any one of the thicknesses described above. In one embodiment, the first and third layers of the multilayer film of the present application are each from about 8% to about 10% of the total weight of the film. In another embodiment, the second layer is about 68% to about 74% of the total weight of the film. In another embodiment, the bonding layers are each from about 4% to about 6% of the total weight of the film.

[0039] The multilayer film of the present application comprises a moisture barrier. Such barrier properties can be provided by one or more of the layers of the film; and the film is suitable, for example, for packaging oral dosage forms for pharmaceutical products. In an embodiment of the multilayer film of the present application, the multilayer film provides a moisture vapor transmission rate of less than 0.0007 grams per well per day, at 40 ° C and 75% relative humidity and less than 0 , 0001 grams per well per day at 23 ° C and 75% relative humidity, when thermoformed in a blister-type package with a size of 00 wells and measured according to USP671. In another embodiment, the multilayer film provides a moisture vapor transmission rate of about 0.0001 to about 0.0005 grams per well per day, at 40 ° C and 75% relative humidity, when thermoformed in a package blister type with size of 00 cavities and measured according to USP671.

[0040] Multilayer films have been described in patent publication no.U.S. 2012/0107542. In contrast, the present application describes a multilayer film comprising a first, a second and a third layer, wherein the first and third layers comprise a substantial and chemically inert halogen-free polymer, and the second layer comprises HDPE, an agent of nucleation, and a hydrocarbon resin, and where the second layer is between the first and the third layers, and where a bonding layer is between the first and the second layers and between the second and the third layers. The multilayer films of the present application are advantageously produced by coextrusion in mold, without the need for additional lamination or coating of the layers, such as coating the substantial and chemically inert halogen-free polymer in the core layer containing polyethylene. Additional advantages include a higher content of high-density polyethylene in a thinner film end product, lower melting temperatures for thermoforming and fewer types of resins in the final film product, as compared to similar films produced by coextrusion processes. blow film.

[0041] The coextrusion of multilayer films can be challenging, due to the difference in the properties of the components of the various layers. For example, it is difficult to coextrude aromatic polyesters, such as PETG, in a thin, outer layer of a multilayer film, especially when adhered to a high density polyethylene layer. The unwanted consequences of these coextrusions include warping of the final films and separation of the screen or delamination of the layers during the coextrusion process. The inventors have found that the use of a coextrusion process in mold with a substantially chemically inert, halogen-free lower viscosity polymer, such as PETG, provides a multilayer film comprising a first layer comprising PETG and a third layer comprising PETG with a second layer comprising HDPE, a nucleating agent and a hydrocarbon resin between the first layer and the third layer, and with a bonding layer between the first and second layers, and between the second and third layers. In one embodiment, such a multilayer film can be produced for a final film thickness of about 0.254 mm (10 mils) to about 0.533 mm (21 mils), with the second layer comprising at least 50% HDPE and up to 95 % by weight of the layer. In certain embodiments, the HDPE content of the second layer is from about 55% to about 70% by weight of the layer; in other embodiments, the HDPE content of the second layer is about 60% to 68% by weight of the layer.

[0042] PETG resins of lower viscosity are typically used in injection molding processes and are considered unsuitable for coextrusion processes, due to their aqueous consistency. Meanwhile, the inventors have surprisingly found that in-mold coextrusion with a first layer comprising low viscosity PETG and a third layer comprising low viscosity PETG with a second layer (core) comprising HDPE, a nucleating agent and a hydrocarbon resin between the first layer and the third layer and with a bonding layer between the first and second layers and between the second and third layers, resulted in a desired multilayer film with high moisture barrier properties, good thermoforming properties and chemical inertia. Such properties are highly desired in packaging for blister-type packaging for solid dosage forms for pharmaceutical products and for packaging for surgical accessories or other medical devices or materials.

[0043] The substantial and chemically inert polymer free of halogens used in the multilayer film of the present application, may have certain rheology profiles that define viscosities that are advantageous for use in a mold coextrusion process. Figure 5 is a graphical representation of an embodiment of an effective rheology profile of a substantial and chemically inert halogen-free polymer. In this modality, the substantially chemically inert halogen-free polymer can have melting viscosities (in Pa ^ s (poise)) at various shear rates (in radian / second) at a temperature of about 220 ° C, starting at lower range to the upper range described in Table 1.

[0044] In Figure 5, the first lower line 510 graphically illustrates the melting viscosities of the lower range described in Table 1. The first upper line 520 graphically illustrates the melting viscosities of the upper range described in Table 1. The first range 530 is the area between the first lower line 510 and the first upper line 520 and, for this modality, is the profile of effective rheology. In this embodiment, for example, the substantial and chemically inert halogen-free polymer has a melting viscosity of about 2,879.5 Pa ^ s (28,795 poise) to about 4,807.7 Pa ^ s (48,077 poise) in shear rate 1 radian / second at a temperature of about 220 ° C. In another embodiment, the substantial and chemically inert halogen-free polymer of Table 1 and Figure 5 is PETG.

[0045] Figure 6 is a graphical representation of another modality of an effective rheology profile of a substantial and chemically inert halogen-free polymer. In this modality, the substantially chemically inert halogen-free polymer can have melting viscosities (in Pa ^ s (poise)) at various shear rates (in radian / second) at a temperature of about 220 ° C, starting at lower range to the upper range described in Table 2.

[0046] In Figure 6, the second lower line 610 graphically illustrates the lower band melting viscosities described in Table 2. The second upper line 620 graphically illustrates the upper band melting viscosities described in Table 2. The second band 630 is the area between the second lower row 610 and the second upper row 620 and, for this modality, is the effective rheology profile. In this embodiment, for example, the substantial and chemically inert halogen-free polymer has a melting viscosity of about 2,879.5 Pa ^ s (28,795 poise) to about 3182.6 Pa ^ s (31,826 poise) in shear rate 1 radian / second at a temperature of about 220 ° C. In another embodiment, the substantial and chemically inert halogen-free polymer of Table 2 and Figure 6 is PETG.

[0047] The melting viscosities described in Table 1, Table 2, Figure 5 and Figure 6 were measured at 220 ° C, according to ASTM D3835 or ISO 11443.

[0048] A cross-sectional view of an embodiment of the multilayer film of the present application is shown in Figure 1. The multilayer film 10 comprises a first substantial and chemically inert halogen-free layer 11, a second polyethylene blend layer 13, a substantial and chemically inert halogen-free third layer 15 and bonding layers 12 and 14. The first and third substantial, chemically inert, halogen-free layers 11 and 15 can comprise PETG. The second polyethylene blend layer 13 may comprise HDPE, a hydrocarbon resin and a nucleating agent. Bonding layers 12 and 14 can comprise a bonding resin, HDPE and a nucleating agent. The polyethylene blend layer 13 may comprise HDPE of about 50% to about 95% by weight of the layer, hydrocarbon resin of about 3% to about 16% by weight of the layer and a nucleating agent of about 0.01% to about 3.0% by weight of the layer. Bonding layers 12 and 14 can comprise a bonding resin of about 70% to about 95% by weight of the layer, HDPE of about 5% to 25% by weight of the layer and the nucleating agent of about 0 , 2% to 3.5% by weight of the layer.

[0049] In one embodiment, the first and third layers 11 and 15 are of substantially the same composition. In another embodiment, the connecting layers 12 and 14 are of substantially the same composition. In an additional embodiment, the first and third layers 11 and 15 are of substantially different composition. In an additional embodiment, the connecting layers 12 and 14 are of substantially different composition. In another embodiment, multilayer film 10 is a five-layer palindromic film.

[0050] A blister-type package, according to one embodiment of the present application, is shown in the perspective view of Figure 2. The blister-type package 40 comprises a plurality of domed receptacles 41. A bottom plan view of a package blister-type, according to another embodiment of the present application, is shown in Figure 3. In Figure 3, blister-type packaging 140 comprises a plurality of domed receptacles 141. Figure 4 is a side plan view of a type-packaging blister, in accordance with an additional embodiment of the present application. In Figure 4, blister pack 240 is shown additionally containing tablets of pharmaceutical products 243 within domed receptacles 241, and such pack is sealed with cover film 244.

[0051] The multilayer film of the present application can be produced in a coextrusion process in a mold. In one embodiment, the coextrusion process in a mold to produce a multilayer film comprises:

[0052] a. forming a first layer comprising a substantial and chemically inert halogen-free layer;

[0053] b. forming a second layer comprising HDPE, a nucleating agent and a hydrocarbon resin;

[0054] c. forming a third layer comprising a substantial and chemically inert halogen-free layer;

[0055] d. forming a bonding layer between the first and second layers and between the second and third layers, wherein the bonding layers comprise a bonding resin, HDPE and a nucleating agent;

[0056] e. coextruding the first, second, third and connecting layers in an extrudate; and

[0057] f. cool the extrudate in a cooling cylinder, forming a five-layer multilayer film.

[0058] In one embodiment, the first, the second, the third and the connecting layers can be coextruded through a flat matrix; in another embodiment, the first, the second, the third and the connecting layers can be coextruded through a slit matrix.

[0059] A blister-type package, according to the present application, can comprise one or more receptacles to contain the item or items to be packed. The receptacles can be shaped to fit the item or items to be packaged, or they can be shaped into various shapes for more general applications. In one embodiment, the blister-type package comprises a plurality of domed receptacles. The plurality of receptacles may be of any shape, but are generally circular or oblong, in a form suitable for containing a pharmaceutical tablet, capsule or gel capsule, and may be receptacles with a flat or round bottom.

[0060] Blister packs, according to the present application, comprise several advantages over blister packs described in the prior art. For example, the packages in this application do not contain any harmful halogenated polymers. In addition, the film of the present application provides a stackable blister type packaging, especially for packaging pharmaceutical product, which does not readily curve. The packaging retains its “flat” relative structure, even after thermoforming, probably because of the palindromic nature of the film. Another advantage, especially for pharmaceutical product packaging, is that the blister type packaging of the present application can be produced in the finishing, filling and existing equipment of many pharmaceutical product manufacturers, and can be thermoformed at a melting temperature. which is generally lower than that of conventional films. The outer layers of PETG are substantially and chemically inert and therefore do not stick unwanted compounds to the composition contained in the packaging, nor cause damage or corrosion to the packaging equipment. The blister-type packaging of the present application also provides a highly desired suitable moisture barrier for the pharmaceutical and medical device or other accessory packaging.

[0061] Blister packs, as well as other thermoformed packs, are typically sealed with a covering material that can comprise polymer film, lacquer, foil, paper or any combination of those mentioned above. The polymeric film can be coated by extrusion. The cover film is typically sealed with a heat activated sealant. In one embodiment, the roofing material comprises sealant and sheet metal coated by extrusion. In another embodiment, the cover material comprises lacquer, foil and sealant coated by extrusion.

[0062] The description above and the following examples illustrate certain modalities of this application and should not be construed as limiting. In addition, the individual modalities described can be combined with one or more additional modalities and such combinations are within the scope of the application. The modifications and adaptations of the various conditions and parameters normally found in the technique will be evident to those skilled in the art, and are considered within the spirit and scope of this application.

EXAMPLES

[0063] Examples 1a and 1b. The following multilayer films were produced in a mold coextrusion process. Generally, the coextruded film in a five-layer mold was produced with the percent compositions, as described in Table 3, for each layer. The total film thickness was about 0.254 mm (10 mils) to about 0.533 mm (21 mils). TABLE 3

TABELA 5

[0064] Example 2. The moisture vapor transfer rate (MVTR) was measured for A - H samples, both as flat sheet film and thermoformed blister packs (flat or round bottom cavities) produced from the film . The flat or round bottom cavities were sized to the standard United States Pharmacopoeia size 00 for capsules. The film compositions for the AH samples are as shown in Table 4. The flat blade MVTR was measured at 38 ° C (100 ° F) and 90% relative humidity in g / M2 / day, according to ASTM F1249, and the results are shown in Table 5. The MVTR was measured for thermoformed blister packs according to USP671 at 23 ° C or 40 ° C and at a relative humidity of 75%. The MVTR results for blister packs are shown in Table 6.

TABLE 5

Claims (26)

1. Multilayer film and thermoformed blister packaging obtained from said film characterized by the fact that it comprises: a. a first layer (11) comprising a substantial, chemically inert halogen-free polymer; B. a second layer (13) comprising high density polyethylene (HDPE), a nucleating agent and a hydrocarbon resin; ç. a third layer (15) comprising a substantial and chemically inert halogen-free polymer; d. a bonding layer (12) between the first and second layers; and is. a bonding layer (14) between the second and third layers; wherein the second layer (13) is between the first (11) and the third (15) layers; and where the multilayer film has an MVTR moisture vapor transfer rate of less than 2.6 g mil / m2 / day when tested by ASTM F1249 under conditions of 37.7 ° C and 90% relative humidity. 2. Film according to claim 1, characterized by the fact that the substantial and chemically inert halogen-free polymer of the first layer (11) or the third layer (15) has a melting viscosity of 2,879.5 Pa ^ s (28,795 poise) at 4,807.7 Pa ^ s (48,077 poise) at a shear rate of 1 radian / second, at a temperature of 220 ° C. 3. Film according to claim 2, characterized by the fact that the substantial and chemically inert halogen-free polymer of the first layer (11) or the third layer (15) has a melting viscosity of 2,879.5 Pa ^ s (28,795 poise) at 3,182.6 Pa ^ s (31,826 poise) at a shear rate of 1 radian / second, at a temperature of 220 ° C. 4. Film according to claim 1, characterized by the fact that the substantial and chemically inert polymer free from halogen is aromatic polyester. 5. Film, according to claim 4, characterized by the fact that the aromatic polyester is PETG. 6. Film according to claim 5, characterized by the fact that PETG has a melting viscosity of 2,879.5 Pa ^ s (28,795 poise) to 4,807.7 Pa ^ s (48,077 poise) at a shear rate of 1 radian / second, at a temperature of 220 ° C. 7. Film according to claim 5, characterized by the fact that PETG has a melting viscosity of 2,879.5 Pa ^ s (28,795 poise) to 3,182.6 Pa ^ s (31,826 poise) at a shear rate of 1 radian / second, at a temperature of 220 ° C. 8. Film according to claim 1, characterized by the fact that at least one bonding layer (12 and 14) comprises a bonding resin, HDPE and a nucleating agent. 9. Film according to claim 8, characterized by the fact that HDPE is present in at least one bonding layer (12 and 14) of about 5% to about 25% by weight of the layer. 10. Film according to claim 9, characterized by the fact that HDPE is present in at least one bonding layer (12 and 14) of 18% to 22% by weight of the layer. 11. Film according to claim 8, characterized by the fact that the bonding resin is present in at least one bonding layer (12 and 14) of 70% to 95% by weight of the layer. 12. Film according to claim 8, characterized by the fact that the nucleating agent is present in at least one bonding layer (12 and 14) from 0.2% to 3.5% by weight of the layer. 13. Film according to claim 1, characterized by the fact that HDPE is present in the second layer (13) from 60% to 95% by weight of the layer. 14. Film according to claim 1, characterized by the fact that the hydrocarbon resin is present in the second layer (13) from 3% to 16% by weight of the layer. 15. Film according to claim 1, characterized by the fact that the nucleating agent is present in the second layer (13) from 0.01% to 3.0% by weight of the layer. 16. Film according to claim 1, characterized by the fact that the nucleating agent comprises salts of zinc glycerolate or calcium hexahydrophthalate. 17. Film according to claim 16, characterized by the fact that the nucleating agent comprises calcium hexahydrophthalate. 18. Film according to claim 1, characterized by the fact that the first layer (11) and the third layer (15) are each 8% to 10% of the total weight of the film. 19. Film, according to claim 1, characterized by the fact that the second layer (13) is from 68% to 74% of the total weight of the film. 20. Film, according to claim 1, characterized by the fact that each bonding layer (12 and 14) is from 4% to 6% of the total weight of the film. 21. Film according to claim 1, characterized by the fact that the bonding layer (12) between the first (11) and the second (13) layers and the bonding layer (14) between the second (13) and the third (15) layers are of substantially the same composition. 22. Film according to claim 1, characterized by the fact that the bonding layer (12) between the first (11) and the second (13) layers and the bonding layer (14) between the second (13) and the third (15) layers are of substantially different composition. 23. Film according to claim 1, characterized by the fact that the first (11) and third (15) layers are of substantially the same composition. 24. Film according to claim 1, characterized by the fact that the first (11) and the third (15) layers are of substantially different composition. 25. Thermoformed blister packaging characterized by the fact that it is formed from a multilayer film, as defined in claim 1. 26. Blister-type packaging according to claim 25, characterized in that the packaging comprises a plurality of domed receptacle portions (41).

Images